The "Angelina Effect" - Genetic Testing Becomes a Global Phenomenon

Angelina Jolie’s actions to undergo a double mastectomy after genetic testing revealed her predisposition to cancer has created an “Angelina Effect” – a growing demand for attaining personal genetic data. In Part Four of our exclusive series with ANZIIF: ‘How Advances in Medical Technology Are Impacting Insurance’, Karen Jones (Partner) and Dominic Flannery (Special Counsel) explore this ripple effect in medical, legal and insurance sectors.

While it’s not a new concept that celebrities set trends, it is in the realm of genetic testing. A recent Harvard Medical School study[1] has revealed that Angelina Jolie’s very public decision to undergo a double mastectomy resulted in a movement globally known as the “Angelina Effect”.

In her 2013 The New York Times[2] opinion piece, Jolie explained the extreme decision to undergo surgery was made after a genetic test revealed her predisposition to cancer as she possessed the BRCA1 marker. In the weeks following her announcement, there was a 64% boost in the number of women undertaking these types of genetic testing in comparison to the year before.[3]

This so-called “Angelina Effect” is just one example of the growing demand for attaining personal genetic data and the questions this now raises for the global health care system. Increasingly, there is an expectation for health providers to have access to the technology as well as being able to interpret the results at consumer level.

To Be or Not To Be

Until recently, people have been in the dark on what their future health has in store. However, the breakthrough of the Human Genome Project in 2003 marked a significant achievement when an international research group was able to demonstrate the ability to sequence the DNA of a species for the purpose of comprehensively testing an individual’s full genetic makeup.[4]

This development not only provided a future diagnosis, but also an avenue for informed decision making and treatment.

Testing can gather information with respect to human genetics, genetic markers and their subsequent relationship to a range of medical conditions. Some of the types of genetic testing include:

Diagnostic testing
Presymptomatic and predictive testing
Carrier testing
Pharmacogenetics, to identify inherited genetic differences in drug metabolic pathways
Prenatal testing
Newborn screening[5]

Murky Territory? Direct to Consumer Testing (DTC)

It is believed that the global genetic testing market will be worth USD$10.4 billion by 2022[6], which includes everything from specialist genetic clinics and laboratories, to the lucrative direct-to-consumer (DTC) market that is gaining increasing momentum.

DTC testing involves consumers purchasing a genetic test directly and collecting a DNA sample at home, or having a blood sample taken at their doctor’s office. After mailing the sample back to a laboratory, they are notified of their results by mail, over the telephone or online, often bypassing the involvement of a medical practitioner[7].

Needless to say, the nature of DTC testing raises numerous concerns relevant to the privacy of the results[8], the risk of the results being misinterpreted due to the complexity of genetic data[9] and the absence of follow up genetic counselling.

Global Challenges

A lack of US government regulation in the DTC market has meant that insurers are now being faced with potential expensive class actions being pursued against their Insured.

A genetic mapping company, 23andMe Inc. is currently being sued in a class action for holding itself out to have Food and Drug Administration (FDA) approval to conduct the tests, despite a series of inaccurate test results, including one that showed a false positive for a mutated BRCA gene (as per Angelina Jolie).

While the FDA has ordered the company to cease providing health-related testing until such time that the company can clinically validate its test results, 23andMe Inc. and its insurer, have been tied up in Federal Court litigation to determine whether indemnity should be granted in defence of the claim, or whether the liability formed an exclusion under the contract of insurance.[10]

Australia’s Medical Response – Proceed with Caution

The Australian Medical Association[11] (AMA) has advocated for the referral based system we currently employ. This system involves a medical practitioner providing a written request to an accredited laboratory for medical testing, and is monitored by the National Association of Testing Authorities, Australia (NATA). This approach is recommended by the AMA as there are concerns over the lack of monitoring of overseas laboratories conducting DTC testing with the accuracy of test results subsequently being questioned. However the power of the internet continues to allow people to organise DTC testing overseas.

The Australian Government National Health and Medical Research Council (NHMRC) recognised this trend and published a statement in December 2014[12], recommending caution in the use of DTC testing in circumstances where:

Testing results can have implications for family members as amendment to the Health Records and Information Privacy Act 2002 (the Health Legislation Amendment Act 2012 NSW), will allow disclosure of genetic information to genetic relatives, when there is a reasonable belief that that disclosure is necessary to lessen or prevent a serious threat to life, health or safety[13].
Consumers may be required to declare their genetic testing results when seeking to obtain life, income protection or travel insurance, which may impact on their ability to obtain the desired cover.
Australian privacy laws cannot protect the security of genetic testing analysed and stored overseas, the results of which may also be sold to a third party.

The NHMRC has encouraged the involvement of general practitioners, geneticists and genetic counsellors in the DTC genetic testing process to provide consumers with balanced information. In doing so, it has stressed that consumers should be aware that DTC genetic tests do not meet the laboratory accreditation standards required in Australia to perform medical testing.[14]

A Human Genetics Advisory Committee was also established to provide advice to NHMRC on the social, ethical and legal implications of human genetics and related technologies[15].

The “Angelina Effect” otherwise continues to impact change. The Health Insurance (BRCA Gene testing) Determination 2017 which commenced on 1 February 2017, has created a new Medicare pathology service that provides a rebate to selected patients for the detection of the cancer gene, to inform their eligibility for targeted cancer therapy treatment under the Pharmaceutical Benefits Schedule (PBS).

Insurance Risks

Whilst Australia has implemented a regulatory approach to genetic testing, the consumer trend to organise DTC testing from overseas appears set to continue. The Royal Australian College of General Practitioners (RACGP)[16] holds concerns that where testing is not conducted or accredited in Australia, the tests may be inaccurate leading to misdiagnosis.

Of further concern is that even where the data is correct from the lab, a practitioner with no formal training in genetics may not be best qualified to comment on such an emerging field, particularly in the absence of follow up genetic counselling.

From an underwriting perspective, the impact of DTC testing and long tail claims resulting from misdiagnosis remains to be seen. It will be important for insurers to accommodate for the variable risks posed by this trend and for the RACGP to provide education and policies to incorporate into a practitioner’s model of care.

A Legal Perspective

From a claims/legal perspective, consider a scenario where a patient consults her GP with the results of a DTC genetic test asking for a medical opinion. The GP subsequently advises that the patient has low-risk factors indicating a heart condition and that the chances of it being a problem are so finite that treatment is not recommended. Fast forward fifteen years and the same patient unexpectedly dies, with an autopsy later revealing it was from the heart condition. The executors of her estate, knowing about her consultation with the GP fifteen years earlier, commence proceedings against the original GP for a failure to treat.

From the GPs perspective, some considerations would include:

does a GPs medical indemnity policy cover the legal costs in defending the claim?
is the interpretation of genetic testing results not obtained through the referral based system excluded under their policy?
could any treatment have been recommended at the time of the consultation?
did any new treatment for this condition emerge after this consultation and if so did the GP have an ongoing duty to advise the patient?

A further concern in the defence of these long tail claims is that Health Practitioner Regulation (NSW) Regulation 2016 only requires medical records to be held for a period of seven years from the date of the last entry, meaning that evidence of the preliminary diagnosis may no longer be available.

What’s Next?

By any objective measure, Angelina Jolie’s actions have created a ripple effect in medical, legal and insurance sectors across the globe.

With the growing use of DTC genetic testing sourced through the internet used for diagnosis, (which don’t meet Australia’s regulated standards), the inherent risks predisposing medical malpractice are high.

How the insurance industry continues to respond to this growth industry is of significance and will require consistent feedback and review from a claims and underwriting perspective.

The “Angelina Effect” – Genetic Testing Becomes a Global Phenomenon